Penile compression device

ABSTRACT

A penile compression device for preventing urinary leaking and method for the same. First and second semi-rigid support arm are connected at opposing ends in their length direction. The support arms are biased towards each other in a resting position. The support arms are compressible from the length direction such that the support arms deform away from each other. An open region is formed between the support arms when the support arms are deformed, and enables penis insertion between the support arms. Releasing compression of the support arms enables the support arms to bias from a deformed position to a clamped position, whereby the support arms compress a male urethra to prevent urinary leakage. An absorbent sleeve may be affixed to the support arms to capture and hold any urine leakage.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part application of U.S.application Ser. No. 11/122,395 entitled “Penile Compression Device”filed on May 5, 2005, which claims the benefit of U.S. ProvisionalPatent Application Ser. No. 60/569,178, filed May 7, 2004, and entitled“External Penile Compression Clamp with Absorbent Attachment”, both ofwhich are herewith incorporated by reference in their entirety.

FIELD

The disclosure herein relates to a penile compression device. Moreparticularly, the disclosure herein relates to a penile compressiondevice and method for the same that externally clamps the penis toprevent urinary leakage.

BACKGROUND

Penile compression clamps are well known and widely used to preventurine leakage. In particular, penile clamps have been applied externallyonto the penis for clamping the same. Such external penile clamps havebeen produced both as long-term reusable devices and also as short-termdevices limited to one-week use. Typically, such devices have beenemployed for use in the inspection and treatment of diseases, wounds andother abnormal conditions of the bodies of humans and lower animals.

For example, Bard, Inc. produces the Cunningham clamp. The Cunninghamclamp provides two pivoting arms connected by a single-hinge. Clamp armsurfaces that face the penis are padded for intended comfort. TheCunningham employs a ratcheted latch to clamp the two arms closertogether and compress the penis. This clamp is reported to be areusable, however, the large clamping forces often lead to pain,swelling and penile skin break down.

The Squeezer Klip™ disclosed in U.S. Pat. No. 6,463,932 provides apadded top and bottom arm in a pivoting configuration. Like theCunningham, the Squeezer Klip™ is a hinged, reusable clamp. The dorsaland ventral arms include pressure-applying projections intended tocontact the urethra, and preferentially apply pressure between thedorsal veins and arteries. The Squeezer Klip™ avoids direct compressionof the neurovascular bundle. Patients are often incapable, however, ofrepeatedly applying the pressure-applying projections to the appropriatelocation to effect urethral closure. A screw mechanism clamps the penisusing a fine compression adjustment via a threaded adjustment knob. Thescrew mechanism, however, requires a higher degree of manual dexterityto adjust compression, which can be difficult for older arthritic men.

The C3 clamp disclosed in U.S. Pat. No. 5,184,629 provides a clampintended for use that is limited to approximately one week. The C3 isconstructed from a co-extruded and thermoformed polyolefin sheet. Theresultant component has two clam shelled halves connected by a hinge.The penis is placed through a portal between the two halves and thehalves are folded over to compress the penis. The clam shells are heldclosed by a Velcro® strap. Force is localized on the urethra by presenceof a raised bump on the bottom clam shell half. The C3 is available inonly two fixed sizes. As there is great penile anatomical variationrequiring multiple clamp sizes, a clamp frequently may be improperlyselected. Further, the ability to operate the strapping system is oftendifficult for older, arthritic men. Such inconsistencies in sizing andthe user dependent strapping system, however, make the C3 less reliablein its ability to control leakage.

None of the clamps above entirely eliminated urinary leakage.

Other clamps have been disclosed in U.S. Pat. Nos. 6,609,522, 6,289,895B1, 6,609,522 B2, and 6,234,174 B1. These patents, however, providedetailed straps, latches, hinges and mechanisms for “dialing” inrequired urethral pressure. Experience with the C3 and such clampsindicate that users may be confused by the added complexity of suchcomponents.

While these clamps provide some advancement for controlling urinarydysfunction and protecting against bladder malfunction, improvements mayyet be made to penile compression devices for males experiencing stressurinary incontinence. There is need for a penile compression device thatprovides optimum comfort and that is easy to apply and remove, whilesufficiently preventing urinary leakage. Improvements may still be madeto a penile compression device that provides an absorbent mechanismconveniently and comfortably attached to the compression device.

SUMMARY

It is a purpose of the present disclosure to overcome thesedifficulties, thereby providing an improved penile compression device.The penile compression device provides a semi-rigid clamp compressiblefrom an initial rest position. Manual compression of the clamp causesshape deformation of the clamp arms forming an open region within theclamp that is appropriate for penis insertion. Releasing compressionallows the clamp to bias back toward the rest position and into a clampposition. In the clamp position, biasing by the clamp sufficientlycompresses the male urethra to prevent urinary leakage.

In one embodiment, a penile compression device includes semi-rigid firstand second support arms connected at opposing ends of their lengthdirection. The support arms are biased toward each other in a restingposition, such that a penis may not be inserted therebetween. Thesupport arms are manually compressible from the length direction. Manualcompression causes shape deformation of the support arms to form an openregion between the support arms and appropriate for penis insertion.Releasing clamp compression allows the support arms to bias to a clampposition. In the clamp position, biasing by the first and second supportarms compresses the male urethra to prevent urinary leakage.

In one preferred embodiment, the first and second semi-rigid supportarms are integrally formed as a single piece, closed biasing structure.The support arms are preformed as a single injection molded plasticstructure.

In another embodiment, one of the first and second semi-rigid supportarms includes an occlusive protrusion disposed on the side surfacethereof. The occlusive protrusion concentrates compression on a maleurethra from the biased support arms.

In another preferred embodiment, each of the first and second semi-rigidsupport arms includes padded foam disposed on the side surfaces thereof.

In yet another embodiment, the first and second support arms areconnected by a hinge connection disposed at each of the opposing ends.

In yet another preferred embodiment, the first and second support armsdefine a two-piece, closed biasing structure. Preferably, the first andsecond support arms each define an injection molded material. Morepreferably, the injection molded material is a plastic materialminimizing deformation.

In another embodiment, a penile compression device further comprises anabsorbent attachment operatively connected to the first and secondsupport arms, the absorbent attachment capturing and holding inadvertenturine leakage.

In yet another embodiment, a penile compression device further comprisesa pressure concentrating insert. The pressure concentrating insert issurgically implanted on a dorsal urethral surface.

Preferably, penile compression device is externally applied to a user.

One embodiment of a method for preventing urinary leakage, includesproviding a penile compression device above. The first and secondsupport arms are compressed from opposing ends in the length direction,so as to deform the support arms. The first and second support arms aredeformed to form the open region. A penis is inserted between the firstand second support arms when the support arms are deformed. Compressionof the support arms is released thereby enabling the support arms tobias from a deformed position to a clamp position, wherein the supportarms bias the support arms toward each other to compress a male urethra.

In another embodiment, the method for preventing urinary leakage furthercomprises operatively connecting an absorbent attachment with thesupport arms. The absorbent attachment captures and holds anyinadvertent urine leakage within the absorbent attachment.

In yet another embodiment, a method for preventing urinary leakageincludes implanting a pressure concentrating insert at a dorsal urethralsurface.

In other embodiments, various other structures can be implemented for apenile compression device and a method of urethral compression. Forexample, the support arms may be joined at their ends by flexible tapes,adhesives, thermal processes, end caps, or through constraint by theabsorbent attachment itself.

The simple use of manual compression and decompression to deform andrelax the penile compression device of the present application is insharp contrast to other more complex clamping mechanisms. The Cunninghamclamp, for example, requires the user to bend its compressive arms to ashape appropriate to their anatomy and then select a ratchet position toprovide adequate compression. The C3 clamp requires that the penis beinserted into the portal between two clam shell halves and that theclamp be squeezed to apply an appropriate load while a Velcro® strap iswrapped around the clamp to secure its closure. The Squeezer Klip™requires the user to operate a threaded adjustment knob to secure theappropriate penile compression.

The penile compression device of the present application providessuitable neurovascular load distribution that can be coupled withlocalized urethral compression. The penile compression device provides auniversally fitting clamp that improves comfort while improving urineleakage prevention.

BRIEF DESCRIPTION OF THE DRAWINGS

Like reference numbers generally indicate corresponding elements in theFigures. The embodiments illustrated are exemplary only and are inaccordance with the inventive principles described herein.

FIG. 1A represents an end view of one embodiment for a penilecompression device. The device is shown applied to a penis illustratedin section where the device is not clamped.

FIG. 1B represents an end view of the penile compression device shown inFIG. 1A. The device is shown applied to the penis illustrated in sectionwhere the device is clamped.

FIG. 2 represents a perspective view of the penile compression device ofFIG. 1A.

FIG. 3A represents a side view of the penile compression device of FIG.1A. The device further illustrates one embodiment for an implantedpressure concentrating insert. The device is shown applied to the penisillustrated in section where the device is not clamped.

FIG. 3B represents a side view of the penile compression device of FIG.1A and including the implanted pressure concentrating insert of FIG. 3A.The device is shown applied to the penis illustrated in section wherethe device is clamped.

FIG. 3C represents another embodiment of an implanted pressureconcentrating insert. The insert is illustrated in an implanted state.

FIG. 4A represents a perspective view of the penile compression deviceof FIG. 1A and further including one embodiment of an absorbentattachment and one embodiment for affixing the penile compression devicewith the absorbent attachment.

FIG. 4B represents an exploded perspective view of the penilecompression device and absorbent attachment shown in FIG. 4A. The penilecompression device is illustrated as being insertable into the absorbentattachment.

FIG. 4C represents a side sectional view of another embodiment foraffixing the penile compression device with the absorbent attachment.

FIG. 4D represents a perspective view of yet another embodiment foraffixing the penile compression device with the absorbent attachment.

FIG. 5 represents a side plan view of yet another embodiment for anabsorbent attachment.

FIG. 6A represents an end view of another embodiment for a penilecompression device. The device is shown applied to a penis illustratedin section where the device is not clamped.

FIG. 6B represents an end view of the penile compression device shown inFIG. 6A. The device is shown applied to the penis illustrated in sectionwhere the device is clamped.

FIG. 7 represents an exploded perspective view of the penile compressiondevice of FIG. 6A.

FIG. 8A represents a perspective view of yet another embodiment of apenile compression device.

FIG. 8B represents an end view of the penile compression device of FIG.8A. The penile compression device is shown applied to a penisillustrated in section where the device is not clamped.

FIG. 8C represents an end view of the penile compression device shown inFIG. 8A. The device is shown applied to the penis illustrated in sectionwhere the device is clamped.

FIG. 9 represents a perspective view of one planar member of the penilecompression device of FIG. 8A in an exploded state.

FIGS. 10A-B is another embodiment of a penile compression device showingtwo support arms that are integrally connected.

FIGS. 11A-B is another embodiment of penile compression device showingtwo support arms joined by flexible tapes.

FIGS. 12A-B is another embodiment of a penile compression device showingtwo support arms joined by a flexible tape wrapped around the supportarms.

FIGS. 13A-B is another embodiment of a penile compression device,showing two support arms inside an absorbent attachment.

FIGS. 14A-B is another embodiment of a penile compression device showingtwo support arms attached at the ends by a thermal or adhesive process.

FIGS. 15A-B is another embodiment of a penile compression device showingtwo support arms joined at the ends by end caps.

DETAILED DESCRIPTION

One exemplary embodiment of a penile compression device 10 is providedin FIGS. 1A-2. As shown in FIGS. 1A-B, the penile compression device 10is illustrated with a penis 3 (shown in section) inserted therethrough.As widely known, the penis 3 includes a urethra 5 and urinary pathway 5a. Other penile tissue is also shown including the corpora cavernosa 7and the dorsal penile neurovascular bundle 9.

The penile compression device 10 includes a closed planar structure 14defining oppositely disposed first and second support arms. The firstand second arms define inner and outer side surfaces. As shown in FIGS.1A-2, the first and second support arms resemble a top support armproximate the dorsal penile neurovascular bundle 9 and a bottom supportarm proximate urethra 5. It will be appreciated that either of the firstor second support arms may be any of the top and bottom arms. Such topor bottom designations are for purposes of describing the illustrationsonly. The first and second support arms are connected at ends of alength direction thereof.

As shown in FIG. 2, the inner side surfaces of the support arms of theplanar structure 14 bias toward each other in a resting position. Thearrow directional of FIG. 1A illustrates the first and second supportarms are compressible from the length direction, such that the innerside surfaces are deformable away from each other. An open region formsbetween the first and second support arms when the support arms aredeformed. The open region enables penis 3 insertion between the firstand second support arms when the support arms are deformed.

As shown in FIG. 1B, releasing compression of the support arms enablesthe support arms to bias from a deformed position back toward the restposition and into a clamp position, whereby the support arms bias theside surfaces toward each other. This action compresses the male urethra5 preventing urinary leakage through the urinary pathway 5 a.

Thus, in operation, manual compression of the penile compression device10 across its sides causes shape deformation appropriate for insertionof the penis 3 into the open region. Releasing compression of the penilecompression device 10 allows biasing toward a clamp position. In theclamp position, compression by the biased support arms is sufficient toprevent urinary leakage through the urethra 5.

An occlusive protrusion 12 may be disposed proximate the urethra 5 onone of the first or second support arms. Preferably, the occlusiveprotrusion 12 is disposed on the bottom support arm proximate theurethra 5. More preferably, the occlusive protrusion 12 is inwardlydirected, and applies localized compression on the urethra 5 from thebottom surface of the penis 3.

Compressing the penile compression device 10 across its sides moves anocclusive protrusion 12 away from the urethra 5 to allow unobstructedurinary voiding through the urinary path 5 a. Compression of the penilecompression device 10 in the length direction also allows removal of thedevice 10 from the penis 3.

As shown in FIGS. 1A-2, the penile compression device 10 may be aone-piece, semi-rigid, and closed biasing structure as shown in FIGS.1A-2. Preferably, the width W of the penile compression device 10 incontact with the top or dorsal surface of the penis 3 (See FIG. 2) maybe maximized to distribute compressive loads and minimize the pressureapplied to the penile tissue and underlying neurovascular bundle 9. Highloads applied to the neurovascular bundle 9 can cause pain and reducedpenile blood flow. The width W may be between 0.25 inches and 1.0 inch.It will be appreciated that these widths are merely exemplary, as otherwidths may be equally or more suitable.

The penile compression device 10 may be generally ovoid in shape with anocclusive protrusion 12 disposed on one of the first or second supportarms. Human penile circumferences usually vary within a range of 6 cm to14 cm. If required, several sizes may be employed to accommodate thevarying penile circumferential sizes and to provide adequate urethralcompression. The wall thickness T of the penile compression device 10may be suitably varied as necessary for optimum structural stiffness.Thereby, optimum urethral compression can be provided, while notrequiring a large manual force to deform the device 10 when operated.

The penile compression device 10 may be manufactured from semi-rigidthermoplastic materials. Such materials may include, but are not limitedto Delrin® (Dupont, Inc.) or a polycarbonate (Entec, Inc.) usingstandard thermoplastic extrusion or injection molding practices. Thepenile compression device 10 may also be manufactured from a springmetal material. Such metal material may be, but is not limited to, ahardened 300 series stainless steel or 17-7PH stainless steel. To closethe structure manufactured from steel sheets, standard sheet metalrolling practices or spot welds may be employed. It will be appreciated,however, that such named plastic and metal materials are exemplary only.Other materials including plastics, metals, and non-plastic andnon-metal materials may be employed, and may be equally or moresuitable. The materials for manufacture may be limited only to suchmaterials having the physical characteristics contemplated for thepenile compression device 10. Such contemplated physical characteristicsinclude the necessary compression and biasing features for the supportarms.

The penile compression device 30 may also be manufactured from multiplecomponents to facilitate use of automated manufacturing processes asshown in FIGS. 6A-B and FIG. 7. The first and second support (top andbottom) arms 34 may be manufactured from thermoplastic or metal asdescribed above. Preferably, the support arms 34 are shaped as planarstrips. The occlusive protrusion 32 is joined to the bottom support arm.Preferably, the occlusive protrusion 32 is a cylindrical member having awidth approximately equivalent to the width of the support arms 34. Thetop and bottom support arms 34 are then joined at their ends lengthwise.The first and second support arms 34 may be joined by use of adhesives,ultrasonic or thermal welding processes. It will be appreciated thatthese joining processes are exemplary only, as other joining methods maybe equally or more suitable. The function and deformation of the penilecompression device 30 is the same as previously described above.

In yet another embodiment, urethral compression may be further maximizedby the surgical implantation of a pressure concentrating insert 19 onthe lop or dorsal urethral surface. The pressure concentrating insert 19provides a backing surface against which the occlusive protrusion 12 maycompress the urethra 5.

FIGS. 3A-C illustrate the penile compression device 10 employed inconjunction with the surgical implantation of an exemplary embodimentfor a pressure concentrating insert 19. The pressure concentratinginsert 19 provides a surface or backing that assists the occlusiveprotrusion 12 in compression of the urethra 5. The surgically implantedpressure concentrating insert 19 is intended to provide a backstop,against which, the penile compression device 10 may compress the urethra5. In this configuration, the pressure concentrating insert 19 canprevent the urethral tissue, namely the urethra 5, from moving away fromthe occlusive protrusion 12 and compress into the other more compliantpenile tissue. It will be appreciated that surgical implantation of thepressure concentrating insert 19 can be accomplished by one of skill inthe medical and surgical arts.

Preferably, the pressure concentrating insert 19 has an arcuate profileto conform to the shape of the dorsal urethral surface. However, thearcuate shape is exemplary only, as other shapes may be equally or moresuitable.

The insert 19 may be manufactured from such rigid materials as 316 LVMstainless steel, 6Al 4V ELI titanium or silicone rubber with a durometerin excess of 35 Shore A. The pressure concentrating insert 19 may alsobe manufactured from softer more flexible materials such as siliconerubber with a durometer no greater than 35 Shore A. This would allowflexing of the insert 19 in response to normal bodily movement.Preferably, the length of the pressure concentrating insert along theurethral axis approximates the mating width of the occlusive protrusion12 on the penile compression device 10. However, it will be appreciatedthat these named materials are exemplary only. Other materials may beused to produce the insert 19.

FIG. 3C also illustrates a pressure concentrating insert 59 in animplanted state and further showing surrounding penile tissue 5 c. Asegment 59 a fixes the pressure concentrating insert 59 to thesurrounding penile tissue 5 c. Preferably, the segment 59 a is aflexible material. The flexible material includes but is not limited toa polyester reinforced silicone sheeting adherent to the back of thepressure concentrating insert 59 to allow fixation of the insert 59 tosurrounding penile tissues 5 c. It will be appreciated that othermaterials, including semi-rigid or rigid materials, may be equally ormore suitable.

Reported clinical experience still might indicate that total urineleakage protection is difficult for penile compression clamps. Thus, inanother preferred embodiment of a penile compression device 10, anabsorbent attachment 20 is attached to the penile compression device 10.As shown in FIGS. 4A-D, the absorbent attachment 20 is designed tocontain the penis 3 in an opening 22 thereof. The absorbent attachment20 absorbs any inadvertent trace or small amount of urine escaping thepenis 3 during usage.

Preferably, the absorbent attachment 20 is an absorbent sleeve 20slipped over the penis 3 and the penile compression device 10 followingdevice 10 placement. In this instance, the sleeve 20 may be attached tothe outer surface of the penile compression device 10 through use of anadhesive surface or strip or use of a Velcro® closure (FIGS. 4A-B).

The absorbent sleeve 20 may be affixed to the penile compression device10 at the time of manufacture by an adhesive, Velcro® closure or thermalweld (FIG. 4C). FIG. 4C illustrates an overlap 26 of the absorbentsleeve 20 and enclosing the penile compression device 10.

The absorbent sleeve 20 may also be placed onto the penis 3 prior toplacement of the penile compression device 10 (FIG. 4D). FIG. 4Dillustrates an arrow directional for the penile compression device 10 tobe slid over the absorbent sleeve 20. Subsequent penile compressiondevice 10 placement will act to anchor the sleeve 20 to the penis 3.

FIG. 5 illustrates an absorbent sleeve 20 a that is tapered along thepenile axis and away from the penile compression device 10. In thisconfiguration, the sleeve 20 a profile is minimized, thereby reducingany unnecessary bulk, which must be concealed within undergarments. Theminimized profile can help avoid discomfort for the user. It will beappreciated that the tapering grade or degree can be suitably varied toaccommodate penile sizes.

Preferably, layers of absorbent material are joined to one another alongbond surfaces 18, so as to form the sleeve 20 a and necessary openingfor receiving the penis 3. More preferably, two halves of absorbent andleak protectant material may be joined together at the bond surfaces 18.Joining processes may include, but are not limited to, adhesives,inclusive of hot melt adhesives, ultrasonic welds and other thermalwelding processes. It will be appreciated, however, that such processesare exemplary only, as other methods may be equally or more suitable.

The absorbent sleeve 20, 20 a may be manufactured from polyurethane opencelled foams or polyolefin open celled foams such as Willsorb®manufactured by Ilibruck, Inc. A water resistant barrier layer may bedisposed and adherent to the outer surface of the foam that will preventinadvertent leakage of any absorbed urine. The absorbent sleeve 20, 20 amay also be manufactured from non-woven, absorbent paper withpolyethylene barrier liners typically used in the construction ofdiapers. Sodium polyacrylate may be used with the nonwoven paper layersto further absorb urine. It will be appreciated that these materials areexemplary only, as other materials may be equally or more suitable as anabsorbent and leak protectant.

Clinical experience with the penile compression device 10 and absorbentattachment 20 might also indicate that an occlusive protrusion, asdisclosed in the above, may not be necessary to prevent urinary leakage.FIGS. 8A-9 illustrate another preferred embodiment for a penilecompression device 40. As shown in FIGS. 8A-8C, the support arms 44 ofthe device 40 are deformable away from each other and bias together.This configuration is similar to that described in the aboveembodiments. Differently, the penile compression device 40 defines atwo-piece, hinged clamp construction. This construction helps preventpermanent deformation of the support arms 44, while enabling onlytemporary deformation and maximizing occlusive ability when in use.

The penile compression device 40 includes two support arms 44 that arehingedly connected by a hook portion 44 a and hook pivot 44 b.Preferably, the support arms 44 are connected by a hinge connectiondisposed at each of the opposing ends.

As shown in FIGS. 8A-9, each support arm 44 includes one hook portion 44a disposed on one end and one hook pivot 44 b disposed on the other end.In this configuration, the two support arms 44 are connected such thatthe hook portion 44 a from one support arm rotatably connects with thehook pivot 44 b of the other support arm. The other hook portion 44 bthen rotatably connects with the other hook pivot 44 b.

It will be appreciated that this configuration is exemplary only, asother configurations may be employed that are equally or more suitable.For example, one support arm 44 may include only hook portions 44 a andthe other support arm 44 may include only hook pivots 44 b. It will alsobe appreciated that the hook/pivot structure is merely exemplary asother connective structures may be employed to mechanically connect thetwo support arms 44.

Preferably, the support arms 44 are snapped together. The penilecompression device 40 may be used alone to compress the penis 3 or beoperatively connected with an absorbent attachment such as 20, 20 adescribed above. More preferably, each support arm 44 includes a layeror strip of padding material 48. Preferably, this padding material 48 isa closed or open celled polyolefin foam that adheres to the innersurface of each support arm 44 to maximize patient comfort. It will beappreciated that a variety of padding materials may be employed, and arenot necessarily limited to a foam material.

The width, length and thickness of each support arm 44 may be altered toadjust the occlusive pressure applied to the penis 3 and urethra 5.Appropriate dimensions necessary to prevent urine leakage, yet maintainpatient comfort, may include but are not limited to approximately awidth of 0.5 inches, a length of 3.0 inches and a thickness of 0.05inches. Preferably, the support arm 44 resembles a planar shaperesembling a rectangular strip. The support arms 44 substantially definetwo straight planar members adjacently connected at ends of their lengthdirection, and are temporarily deformable by compression from the ends.Releasing compression from the sides enables the support arms 44 to biasback toward its rest position shown in FIG. 8A.

More preferably, each support arm 44 of the penile compression device 40may be injection molded from a thermoplastic such as HYLEXpolycarbonate, which minimizes plastic deformation. As the support arms44 are substantially straight planar members, employing such a materialwith this configuration prevents permanent deformation of the device 40.It will be appreciated, however, that the shape and manufacturingmaterials may be suitably varied as necessary to accomplish the physicalcharacteristics of the device 40.

As illustrated, the penile compression device 40 is shown without anocclusive protrusion. It will be appreciated that an occlusiveprotrusion, such as any of the occlusive protrusions detailed above, maybe employed on one of the support arms 44. In a configuration includingan occlusive protrusion, the penile compression device 40 may initiallybe in a slightly deformed position, rather than the adjacently disposedsupport arms shown in FIGS. 8A-C. The penile compression device 40 maythen be further deformed as described to insert a penis and therebycompress a male urethra. It will be appreciated that the presence of anocclusive protrusion, if at all, does not compromise the support armbiasing ability, and suitable urethral compression may be maintained.

In addition to the embodiments described above, various other structuresfor a penile compression device can be implemented for a penile clamp toachieve desired penile compression. Several additional embodiments aredescribed below. Similar to FIGS. 1A-3B, a one piece clamp structure caninclude support arms that are joined at their ends by an integrallymolded connection (see FIGS. 10A-B below). In other embodiments, thesupport arms may be joined at their ends by flexible tapes, adhesives,thermal processes, end caps, or through constraint by the absorbentattachment itself (see FIGS. 11A-15B below).

Similar to the embodiment shown in FIGS. 1A-3 b, FIGS. 10A and B show apenile clamp 60 that may be formed as a one-piece integral structure.The clamp includes opposing support arms 62 that are integrally formedat ends 66 in a generally closed planar structure 64. The opposingsupport arms 62 have a spring-like bias established between them toallow compression of the penis and urethra to prevent urinary leakage.As shown in FIG. 10A, the clamp 60 generally has a normally closedposition where the support arms 62 biased toward each other. Applyingmanual force at either end 66 deforms the support arms 62 away from oneanother to allow insertion of the penis, or to remove compressive forcefrom the penis and remove the clamp (see arrows of FIG. 10B). The springbias of the support arms 62 is facilitated by junctions between the ends66 of the support arms 62, which are formed as integral parts of theclamp 60. For example, the nature of the material for the clamp 60including at least at the ends 66 of the support arms 62 allows forbending when the clamp 60 is compressed from the ends 66, while alsoallowing the clamp 60 to return to its original normally closed positionwhen compression on the ends 66 is released. FIG. 10A shows theintegrally molded connection of the support arms 62, and FIG. 10B showsthe clamp in the open position when compressed or flexed.

The clamp may be formed by plastic injection molding or extrusion.Materials which may be employed using these processes include variousgrades of polycarbonate or acetal thermoplastics. The clamp may also beformed from plastic strips which are thermally formed into the net shapeof the clamp. The support arms can be joined at the free ends byadhesives, adhesive tapes or thermal processes such as heat staking orultrasonic welding (see also following embodiments). Likewise, metalstrips may be mechanically bent to the net shape of the clamp and joinedat their free ends by adhesives, adhesive tapes or metal weldingprocesses (see also following embodiments). Metals which may be usedinclude, but are not limited to various grades of stainless steel andhigh carbon steels.

As further shown in FIGS. 1A-B, the clamp 60 may be permanently orremovably attached to an absorbent attachment 68. The absorbentattachment 68 may be structured and constructed of materials assimilarly described above, where the clamp 60 is attached to theabsorbent attachment 68 at the outer surface of an absorbent attachment(shown), on inner surfaces of the absorbent attachment (not shown butsee e.g. FIGS. 4A-B), as well as at the end of the absorbent attachment.

FIGS. 11A-B show another clamp 80, where flexible tapes are employed tojoin ends of the clamp 80. The clamp 80 includes opposing support arms82 that are joined at the ends by flexible end tapes 86 so as to form agenerally closed planar structure 84. FIG. 11A shows the flexible endtapes 86 at junctions of the support arms 82. The support arms 82 formthe clamp 80 when joined at their free ends by the flexible end tapes 86(see ends of support arms 82 inside the end tapes 86 in FIG. 11B). Theflexible end tapes 86 maintain the inward spring bias of the opposingclamp arms 82 by preventing or minimizing the separation of the supportarms 82 from one another. In some embodiments, non-reinforced or fabricreinforced adhesive backed tapes can be used as the flexible end tapes86. As other examples, flexible plastic, rubber, or fabric non-adhesivebacked tapes may be employed with attachment between the tapes andsupport arms being made by a separate application of an adhesive orthrough a thermal process such as radio frequency or ultrasonic welding.

As above, the support arms 82 may be manufactured from plastic or metalmaterials. Further shown in FIGS. 11A-B, the clamp 80 may be permanentlyor removably attached to an absorbent attachment 88. The absorbentattachment 88 may be structured and constructed of materials assimilarly described above, and the clamp 80 can be attached to theabsorbent attachment 88 at either the outer surface or inner surface ofan absorbent attachment, as well as at the end of the absorbentattachment.

Alternatively, the flexible tape may surround the entire periphery ofthe clamp. FIGS. 12A-B show another clamp 100, where a flexible tape 106surrounds the support arms 102 thus surrounding generally the entireouter surface of the clamp 100. The clamp 100 includes opposing supportarms 102 that are joined by the flexible tape 106 so as to form agenerally closed planar structure 104. The support arms 102 are joinedat ends by the flexible tape 106 which wraps around the entire peripheryof the clamp 100 and surrounds the outer surface of the support arms102. In addition to the materials and joining methods already describedabove, the tape can be held in place using a variety of mechanicalstructures. As one example hook and loop tape materials such as Velcro®can be used.

As with the previous clamps described, the clamp 100 may be permanentlyor removably attached to an absorbent attachment 108. The absorbentattachment 108 may be structured and constructed of materials assimilarly described above, and the clamp 100 can be attached to theabsorbent attachment 108 at either the outer surface or inner surface ofan absorbent attachment, as well as at the end of the absorbentattachment.

In an attempt to simplify construction of the device and reduce itsmanufacturing costs, the separate clamp support arms may be held inplace and constrained at their mating ends by the walls of the absorbentattachment without the need for tapes. FIGS. 13A-B show another clamp120 that includes support arms 122 forming a generally closed planarstructure 124 by being constrained by walls of an absorbent attachment128. As shown, the walls of the absorbent attachment 128 generallysurround the outer surface of the clamp 120 (shown). FIG. 13A shows thesupport arms 122 on inside walls of the absorbent attachment 128. FIG.13B shows the support arm 122 constrained by the walls of the absorbentattachment 128 (see support arm ends inside the clamp). It will beappreciated that the walls of the absorbent attachment can surround theinner surface of the clamp 120 (e.g. support arms 122), for example whenthe support arms 122 are disposed on an outer surface of the absorbentattachment 128. As one preferred implementation, the walls of theabsorbent attachment 128 walls are of sufficient strength to resist theforces imparted by the free ends 126 of the support arms 122.

The absorbent attachment 128 can be structured and constructed ofmaterials that include fabric reinforced materials which have highertensile strengths to resist loads of the support arm 122, such as whenthe support arms 122 are compressed.

FIGS. 14A-B show another embodiment of a clamp 140. The clamp 140includes opposing support arms 142 that are formed as a generally closedplanar structure 144. The clamp 140 is similarly constructed as clamps10, 60, but show elongated ends 146 of the support arms 142. In someembodiments, the support arms 142 arejoined at free ends 146 through theuse of adhesives, radio frequency or ultrasonic welding (plastic supportarms) or adhesives, metal welding techniques (metal support arms). Inother embodiments, the support arms 142 are attached at ends 146 by athermal process.

As with the previous clamps described, the clamp 140 may be permanentlyor removably attached to an absorbent attachment 148. The absorbentattachment 148 may be structured and constructed of materials assimilarly described above, and the clamp 140 can be attached to theabsorbent attachment 148 at either the outer surface or inner surface ofan absorbent attachment, as well as at the end of the absorbentattachment.

FIGS. 15A-B show another embodiment of a clamp 160. The clamp 160includes opposing support arms 162 that are formed as a generally closedplanar structure 164 by using end caps 166. As shown, the free ends ofthe support arms 162 are constrained and held together by end caps 166.In one preferred implementation, the end caps 166 are elastomeric andcan stretch as the clamp is deformed (e.g. compressed to open state, seeFIG. 15B) and returns to its original shape when compression of theclamp 160 is released and the clamp is allowed to return to itsunstressed state. In some embodiments, the end caps 166 may bemanufactured from, but are not limited to, materials such as silicone orbutyl rubber and polyurethane.

As with the previous clamps described, the clamp 160 may be permanentlyor removably attached to an absorbent attachment 168. The absorbentattachment 168 may be structured and constructed of materials assimilarly described above, and the clamp 160 can be attached to theabsorbent attachment 168 at either the outer surface or inner surface ofan absorbent attachment, as well as at the end of the absorbentattachment.

While the above clamps in FIGS. 10A-15B do not show an occlusiveprotrusion, it will be appreciated that any of the clamps described mayincorporate the use of an occlusive protrusion according to theprinciples described. Likewise, the clamps of FIGS. 10B-15B canincorporate the use of any of the absorbent attachments, sleeves alreadydescribed and can incorporate the use of an additional padding material(e.g. padding material 48) on the support arms. Even further, any of theclamps of FIGS. 10A-15B can be used in conjunction with the pressureconcentrating inserts (e.g. pressure concentrating inserts 19, 59)already described.

The penile compression device and the above provide suitableneurovascular load distribution that can be coupled with localizedurethral compression. The penile compression device provides auniversally fitting clamp that improves comfort and is user friendly,while improving urine leakage prevention.

Applicants provide some of the following examples of uses for thedevices and methods described herein.

Uses Stress Urinary Incontinence

As discussed above, the devices and methods described herein can be usedby men suffering from stress urinary incontinence (SUI) which is theinvoluntary loss of urine during activities such as coughing, sneezing,laughing or exercising. Alternate uses have been identified whichinclude bladder training and anesthetic retention.

Bladder Training

The symptoms of SUI may vary from minor, occasional leakage to acomplete inability to retain urine in the bladder. In this more extremeinstance, the bladder is never stretched to its full capacity andgradually atrophies which further limits its urine storage capability. Abladder training program may be employed where by the patient wears anyof the devices described herein and optionally with an absorbentattachment for several hours at a time. In so doing, urine can beprevented from leaving the bladder and the bladder walls are stretched.A repeated program of bladder stretching exercises can reshape thebladder and return lost urine storage capacity.

Anesthetic Retention

Passage of catheters, urethroscopes and cystoscopes through the maleurethra is often preceded by instillation of an anesthetic agent intothe urethral lumen. Retention of this anesthetic agent can beaccomplished by placing any of the devices described herein andoptionally with an absorbent attachment over the distal end of the penisto prevent anesthetic leakage. Holding the anesthetic within the urethrafor a period of 10 to 30 minutes can be sufficient to effect ananesthetic effect and allow relatively pain free passage of the catheteror scope.

The above specification provides a complete description of thecomposition, manufacture and use of the improved penile compressiondevice in accordance with the principles of the present invention. Sincemany embodiments of the invention can be made without departing from thespirit and scope of the invention, the invention resides in the claimshereinafter appended.

1. A penile compression device, comprising: a first semi-rigid supportarm; a second semi-rigid support arm, the first and second semi-rigidsupport arms being connected at opposing ends of a length directionthereof, the semi-rigid support arms being biased toward each other in aresting position, and are compressible from the length direction suchthat the semi-rigid support arms are deformable away from each other,the first and second semi-rigid support arms have an open region formedbetween the first and second semi-rigid support arms when deformed, theopen region enabling penis insertion between the semi-rigid supportarms, and releasing compression of the first and second semi-rigidsupport arms enabling the semi-rigid support arms to bias from adeformed position to a clamp position, whereby the semi-rigid supportarms bias toward each other to compress a male urethra and preventurinary leakage; and an absorbent attachment connected to the first andsecond semi-rigid support arms, the absorbent attachment capturing andholding inadvertent urine leakage, and the first and second semi-rigidsupport arms being connected at opposing ends by one of: an integrallyformed connection, where the opposing ends are integrally formed so thatthe first and second semi-rigid support arms are a single, unitarystructure; flexible tapes disposed on the opposing ends; a flexible tapedisposed around the outer surface of the first and second semi-rigidsupport arms; end caps disposed over the opposing ends; and walls of theabsorbent attachment that contact the first and second semi-rigidsupport arms and that constrain the first and second semi-rigid supportarms.
 2. The penile compression device according to claim 1, wherein oneof the first and second semi-rigid support arms including an occlusiveprotrusion disposed on an inner side surface thereof, the occlusiveprotrusion capable of concentrating compression on a male urethra whenthe first and second semi-rigid support arms are biased toward eachother.
 3. The penile compression device according to claim 1, whereineach of the first and second semi-rigid support arms including a foamdisposed on an inner side surface thereof.
 4. The penile compressiondevice according to claim 1, wherein the first and second semi-rigidsupport arms are an injection molded material.
 5. The penile compressiondevice according to claim 1, wherein the absorbent attachment isreleasable from connection with the first and second semi-rigid supportarms.
 6. The penile compression device according to claim 1, wherein theabsorbent attachment is a sleeve enabling penis insertion therein, thesleeve is configured to envelop the penis and contain inadvertent urineleakage.
 7. The penile compression device according to claim 1, whereinabsorbent attachment is attached to outer surfaces of the first andsecond semi-rigid support arms or inner surfaces of the first and secondsemi-rigid support arms.
 8. The penile compression device according toclaim 1, wherein the absorbent attachment is disposed through theopening of the first and second semi-rigid support arms, such that thesemi-rigid support arms are slidable over the absorbent attachment andare configured to anchor the absorbent attachment, when the absorbentattachment is placed onto the penis and when the semi-rigid support armsare in the clamp position.
 9. The penile compression device according toclaim 1, further comprising a pressure concentrating insert, thepressure concentrating insert is surgically implanted on a dorsalurethral surface.
 10. The penile compression device according to claim9, wherein the pressure concentrating insert including a width along aurethral axis that is equivalent to a width of the occlusive protrusion.11. The penile compression device according to claim 9, wherein thepressure concentrating insert having an arcuate shape and substantiallycontouring the dorsal urethral surface.
 12. The penile compressiondevice according to claim 1, further comprising a deforming positionwhen the first and second semi-rigid support arms are compressed fromthe length direction such that the semi-rigid support arms are deformedaway from each other so as to allow insertion or removal of a penisbetween the semi-rigid support arms.